Effect of tadalafil 5mg daily treatment on the ejaculatory times, lower urinary tract symptoms and erectile function in patients with erectile dysfunction

ABSTRACT

INTRODUCTION

Premature ejaculation (PE) represents one of the most prevalent disorders affecting sexual function in men, with occurrence rates ranging from 9% to 30%. PE is clinically defined as ejaculation that occurs with minimal sexual stimulation, occurring either before or shortly after penetration, ultimately resulting in significant anxiety and distress for the individuals affected. The involuntary nature of PE often leaves patients feeling a lack of control over their sexual experience. It is categorized into two types: lifelong (primary) and acquired (secondary). Current literature suggests both psychogenic factors and performance anxiety as key contributors to the condition, alongside organic factors identified as significant predictors, including hormonal imbalances, prostatitis, and erectile dysfunction itself. Notably, while many cases of lifelong PE do not coincide with erectile dysfunction, a substantial percentage of men diagnosed with erectile dysfunction experience PE as a concurrent issue. Large-scale surveys in diverse populations have consistently observed that the coexistence of these conditions is common, prompting further investigation into their interrelationship.

Research in this area emphasizes that the efficacy of PE treatments often hinges on the measurement of ejaculatory latency, specifically utilizing the intravaginal ejaculation latency time (IELT) as a metric for gauging treatment success. Traditionally, therapeutic approaches to PE include both behavioral methods and pharmacological interventions, with serotonin reuptake inhibitors (SSRIs) frequently noted as the first-line pharmacological treatments. Additionally, phosphodiesterase type 5 inhibitors (PDE5 inhibitors), including tadalafil and sildenafil, have emerged as viable alternatives to manage both erectile dysfunction and its accompanying symptoms of premature ejaculation. Recent studies have hinted at the positive implications of PDE5 inhibitors on ejaculatory control, with specific emphasis on the daily use of 5mg tadalafil demonstrating promising results. However, literature concerning the specific impacts of this dosage on ejaculatory timing in the context of erectile dysfunction remains scarce.

In light of these observations, the present study was designed to rigorously assess the effects of a daily regimen of 5mg tadalafil on ejaculatory timing, erectile functioning, and lower urinary tract symptomatology in patients diagnosed with erectile dysfunction, providing valuable insights into the therapeutic potential of this treatment protocol.

MATERIALS AND METHODS

For this study, 60 patients presenting with complaints of erectile dysfunction to the urology clinic between January 2015 and January 2016 were recruited. The research protocol received ethical approval from the local committee of Erzincan University, and informed consent was obtained from all participants. Inclusion criteria necessitated that all participants were heterosexual males involved in a stable sexual relationship for a minimum duration of six months. Candidates were excluded based on a range of criteria including neurological conditions like depression, Parkinson’s disease, and diabetic neuropathy, as well as urinary tract infections, a history of chronic prostate conditions, substance abuse, pelvic trauma, hormonal disorders, and any use of medications impacting sexual function or hormonal balance within the previous three months. Detailed personal and health histories were collected through structured interviews, supplemented with thorough physical examinations. The IELT was meticulously evaluated through self-report measures, with female partners timing ejaculation via stopwatch during intercourse. The time interval from vaginal penetration to ejaculation was recorded in minutes, with occurrences before penetration noted as zero minutes. Erectile function was assessed utilizing the IIEF-5 questionnaire, classifying patients into severe, moderate, or mild ED categories based on their scores. Furthermore, LUTS were assessed utilizing the IPSS, with fasting blood samples drawn to evaluate metabolic parameters including glucose levels, testosterone, and cholesterol profiles.

For treatment, participants were prescribed 5mg of tadalafil daily over a period of three months. After completion, follow-up evaluations were conducted using IIEF-5, IELT, and IPSS to gauge outcomes, while also documenting any adverse effects experienced during treatment.

RESULTS

The average age of the study participants was recorded as 50.4 years (±7.9), with serum total testosterone, fasting glucose, and lipid profiles established as baseline metrics for evaluation. The pre-treatment scores for IELT yielded an average of 2.2 minutes, with substantial improvements noted post-treatment. Specifically, average IIEF-5 scores rose significantly while IPSS scores exhibited a noteworthy decrease, reflecting amelioration in both erectile function and LUTS post-treatment. Statistical analysis corroborated significant enhancements across all evaluated parameters following three months of tadalafil administration, with p values signifying strong therapeutic efficacy.

Table-2 presents a detailed comparison of baseline and post-treatment scores for IELT, IIEF-5, and IPSS. The side effects observed included gastrointestinal issues or nausea in 10% of patients, with headaches reported by 8.3%. Flushing was noted in 5% of cases, and muscle or lower back pain occurred in 3.3%. Notably, most side effects were transient and subsided over time.

DISCUSSION

This investigation centered on the effectiveness of tadalafil 5mg daily treatment in enhancing ejaculatory timing, managing erectile dysfunction, and addressing lower urinary tract symptoms. Recent meta-analyses have underscored the strong association between premature ejaculation and erectile dysfunction, with evidence suggesting that PE notably increases the risk of developing ED. Concurrently, studies indicate that psychological factors such as anxiety and depression extensively exacerbate this risk. The interaction between PE and ED appears cyclical, with each condition potentially exacerbating the other. Indeed, patients often find themselves in a vicious cycle where the stress of managing PE leads to difficulties in maintaining an erection, thus further aggravating the problem of premature ejaculation.

The literature identifies several treatment modalities for PE, which include both behavioral techniques and pharmacological options, with SSRIs being the predominant choice. Nevertheless, phosphodiesterase type 5 inhibitors have also garnered interest for their dual action in managing erectile dysfunction and premature ejaculation. The cumulative evidence suggests that PDE5 inhibitors can enhance ejaculatory control, particularly with consistent daily administration. The present study reinforces these findings, demonstrating that 5mg daily tadalafil significantly enhances IELT and overall sexual satisfaction. Interestingly, the observed increase in IELT was around 1.2 minutes—a critical improvement that may translate to enhanced psychological wellbeing.

Despite the strengths of this study, including an adequately powered sample size and rigorous methodological approach, limitations exist. The absence of a placebo or non-ED control group may affect the interpretation of results, and the relatively short follow-up period necessitates cautious extrapolation of findings to broader populations. Nevertheless, the evidence presented here supports the clinical utility of daily tadalafil in addressing both erectile dysfunction and accompanying premature ejaculation.

In summary, the regular administration of 5mg tadalafil is proposed as a beneficial therapeutic approach in the management of erectile dysfunction, highlighting its role in ameliorating premature ejaculation. Future research endeavors should aim to include larger cohorts with placebo controls and extended follow-up periods to further validate these findings and expand our understanding of tadalafil's multifaceted impact on male sexual health.

REFERENCES